IRB Compliance Monitoring Specialist (Office of Human Subjects Research)
We are seeking an IRB Compliance Monitoring Specialist who will be part of a team that supports the JHM Institutional Review Boards (IRBs). This role conducts internal compliance monitoring of IRB-approved human subject research and prepares summary reports.
Specific Duties & Responsibilities
ā¢ Schedule and conduct, monitoring reviews for IRB approved studies
ā¢ Conduct pre and post enrollment research record reviews for IND/IDE sponsor investigators to
ā¢ Review the available FDA required documentation for completeness and accuracy,
ā¢ Familiarize sponsor investigators with applicable FDA regulations and responsibilities relative to their role and proper conduct of the trial,
ā¢ Discuss and evaluate provisions for monitoring, investigative product accountability, study-team member supervision and training, and maintenance of records.
ā¢ Review regulatory materials and research participant records to ensure compliance with the approved study protocol and the conduct of the clinical trial.
ā¢ During the review, prepare a written report of findings and observations.
ā¢ Discuss with principal investigators and study team members the regulatory and participant review findings, to reconcile compliance issues and provide corrective action recommendations based on regulatory requirements and best-practices
ā¢ Provide support and resources based on regulatory requirements and best practices.
ā¢ Finalize and submit written reports of monitoring findings and recommendations for review by the Institutional Review Board.
ā¢ Participate in Compliance Monitoring Program (CMP) educational activities to improve compliance and convey best-practices techniques to enhance compliance.
ā¢ Conduct customized research compliance in-service training sessions at the request of JHM departments or divisions.
ā¢ Serve as a resource for inquiries from the JHU research community regarding institutional policies and FDA regulations.
ā¢ Provide practical recommendations to implement strategies to increase regulatory and subject compliance
ā¢ Ability to establish priorities, work independently, and proceed with objectives in a fast-paced, online environment.
ā¢ Other duties as assigned.
Minimum Qualifications
ā¢ Bachelor's Degree.
ā¢ Three years of related clinical/medical research experience.
ā¢ Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Classified Title: IRB Compliance Monitoring Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $48,000 - $84,100 Annually ($50,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday - Friday 8:30am - 5:00pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Admin Clinical Invest Human Subjects
Personnel area: School of Medicine
Apply Now
Apply Now
Specific Duties & Responsibilities
ā¢ Schedule and conduct, monitoring reviews for IRB approved studies
ā¢ Conduct pre and post enrollment research record reviews for IND/IDE sponsor investigators to
ā¢ Review the available FDA required documentation for completeness and accuracy,
ā¢ Familiarize sponsor investigators with applicable FDA regulations and responsibilities relative to their role and proper conduct of the trial,
ā¢ Discuss and evaluate provisions for monitoring, investigative product accountability, study-team member supervision and training, and maintenance of records.
ā¢ Review regulatory materials and research participant records to ensure compliance with the approved study protocol and the conduct of the clinical trial.
ā¢ During the review, prepare a written report of findings and observations.
ā¢ Discuss with principal investigators and study team members the regulatory and participant review findings, to reconcile compliance issues and provide corrective action recommendations based on regulatory requirements and best-practices
ā¢ Provide support and resources based on regulatory requirements and best practices.
ā¢ Finalize and submit written reports of monitoring findings and recommendations for review by the Institutional Review Board.
ā¢ Participate in Compliance Monitoring Program (CMP) educational activities to improve compliance and convey best-practices techniques to enhance compliance.
ā¢ Conduct customized research compliance in-service training sessions at the request of JHM departments or divisions.
ā¢ Serve as a resource for inquiries from the JHU research community regarding institutional policies and FDA regulations.
ā¢ Provide practical recommendations to implement strategies to increase regulatory and subject compliance
ā¢ Ability to establish priorities, work independently, and proceed with objectives in a fast-paced, online environment.
ā¢ Other duties as assigned.
Minimum Qualifications
ā¢ Bachelor's Degree.
ā¢ Three years of related clinical/medical research experience.
ā¢ Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Classified Title: IRB Compliance Monitoring Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $48,000 - $84,100 Annually ($50,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday - Friday 8:30am - 5:00pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Admin Clinical Invest Human Subjects
Personnel area: School of Medicine
Apply Now
Apply Now